NCT05105620

Brief Summary

Diabetic macular edema (DME) is one of the leading causes of visual impairment in patients with diabetes. Fluorescein angiography (FA) plays an important role in diabetic retinopathy (DR) staging and evaluation of retinal vasculature. However, FA is an invasive technique and does not permit the precise visualization of the retinal vasculature. Optical coherence tomography (OCT) is a non-invasive technique that has become popular in diagnosing and monitoring DR and its laser, medical, and surgical treatment. It provides a quantitative assessment of retinal thickness and location of edema in the macula. Automated OCT retinal thickness maps are routinely used in monitoring DME and its response to treatment. However, standard OCT provides only structural information and therefore does not delineate blood flow within the retinal vasculature. By combining the physiological information in FA with the structural information in the OCT, zones of leakage can be correlated to structural changes in the retina for better evaluation and monitoring of the response of DME to different treatment modalities. The occasional unavailability of either imaging modality may impair decision-making during the follow-up of patients with DME. The problem of medical data generation particularly images has been of great interest, and as such, it has been deeply studied in recent years especially with the advent of deep convolutional neural networks(DCNN), which are progressively becoming the standard approach in most machine learning tasks such as pattern recognition and image classification. Generative adversarial networks (GANs) are neural network models in which a generation and a discrimination networks are trained simultaneously. Integrated network performance effectively generates new plausible image samples. The aim of this work is to assess the efficacy of a GAN implementing pix2pix image translation for original FA to synthetic OCT color-coded macular thickness map image translation and the reverse (from original OCT color-coded macular thickness map to synthetic FA image translation).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
708

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 3, 2021

Completed
Last Updated

November 5, 2021

Status Verified

November 1, 2021

Enrollment Period

2.5 years

First QC Date

October 26, 2021

Last Update Submit

November 4, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Fréchet inception distance (FID) score.

    1 day

Interventions

Fluorescein Angiography for pateints with diabetes using fundus camera (TRC-NW8F retinal camera; Topcon Corporation, Tokyo, Japan).

Optical coherence tomography for pateints with diabetes using • Topcon DRI OCT Triton device (ver.10.13; Topcon Corporation, Tokyo, Japan).

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients from the retina clinic in Assiut University Hospital who had simultaneously undergone same-day FA and OCT with a diagnosis of confirmed or suspected DME between Augyst 2018 and February 2021.

You may qualify if:

  • Patients from the retina clinic in Assiut University Hospital who had simultaneously undergone same-day FA and OCT with a diagnosis of confirmed or suspected DME.

You may not qualify if:

  • Significant media opacity that obscured the view of the fundus
  • OCT images with high signal-to-noise ratio expressed by the device as"TopQ image quality," below 60
  • Vitreoretinal interface disease distorting the OCT thickness map.
  • Patients with concurrent ocular conditions interfering with blood flow
  • Patients with uveitic diseases
  • High myopia of more than -8.0 diopters.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Related Publications (1)

  • Abdelmotaal H, Sharaf M, Soliman W, Wasfi E, Kedwany SM. Bridging the resources gap: deep learning for fluorescein angiography and optical coherence tomography macular thickness map image translation. BMC Ophthalmol. 2022 Sep 1;22(1):355. doi: 10.1186/s12886-022-02577-7.

MeSH Terms

Conditions

Eye DiseasesDiabetic Retinopathy

Interventions

Fluorescein AngiographyTomography, Optical Coherence

Condition Hierarchy (Ancestors)

Retinal DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

AngiographyDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, OphthalmologicalTomography, OpticalOptical ImagingDiagnostic ImagingTomographyInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of Ophthalmology

Study Record Dates

First Submitted

October 26, 2021

First Posted

November 3, 2021

Study Start

August 1, 2018

Primary Completion

February 1, 2021

Study Completion

February 1, 2021

Last Updated

November 5, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations